Grant: Project Grant

Sleep apnea is a prevalent chronic disease affecting 3% to 50%, commonly treated with positive airway pressure therapy (PAP), which improves health and quality of life. In June 2021, Philips Respironics, one of the largest PAP manufacturers in Canada, issued a recall notification via Health Canada related to irritant and toxic effects from the degradation of polyester-based polyurethane foam in most PAP devices distributed between 2009 and 2021. The recall affects about 3 million to 4 million devices worldwide, potentially causing serious health issues, such as cancer, allergy-related, lung, kidney and liver diseases. The PAP recall is supported by limited data on adverse effects, making it difficult to know what to do. Further, many individuals may be unaware that they are using a defective device, potential risks and what to do if problems arise. Information on the recall impact is needed to know what to do with current and future recalls in a fragmented sleep health system in Canada. We will use different methods to (1) UNDERSTAND health impacts associated with the use of PAP devices affected by the recall; (2) EXPLORE how device recall impacts device users, health care providers and sleep medicine health services; and (3) DEVELOP strategies to help with future device recalls. First, we will use data from health encounters and existing Canadian sleep registries to investigate the link between the PAP device manufacturer and health issues included in the recall, such as cancer, lung, atopic, kidney and liver diseases. Next, we will use data from health encounters to determine whether the recall has affected the sleep health services (visits, sleep tests, PAP claims). We will learn about the recall process and associated challenges from patients, health professionals, equipment providers, and policymakers through surveys and telephone interviews. Finally, we will compile collected data to inform current clinical care and to create national recommendations.